Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07444437

A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer

Led by Suzhou BlueHorse Therapeutics Co., Ltd. · Updated on 2026-05-13

45

Participants Needed

5

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.

CONDITIONS

Official Title

A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old at the time of informed consent
  • Expected survival time longer than 3 months
  • ECOG performance status of 0 or 1
  • Pathologically diagnosed with resectable non-small cell lung cancer
  • Received preoperative neoadjuvant therapy including PD-1 antibody
  • Negative for driver gene mutations
  • No disease recurrence after surgery
  • Expected to complete standard adjuvant therapy
  • Tumor lesions suitable for surgical resection or biopsy
  • Sufficient blood and organ function
  • Voluntarily signed informed consent form
Not Eligible

You will not qualify if you...

  • History of other malignant tumors within the past 5 years, except certain well-treated cancers
  • Unresolved adverse reactions from previous treatments above grade 1 (with some exceptions)
  • Previous severe immune-related adverse reactions (grade 4 or higher) from immunotherapy
  • Received vaccination within 2 months before consent or plans to receive vaccination during study
  • Received TIL, allogeneic T cell, or NK cell therapy within 6 months before consent
  • Previous allogeneic stem cell or solid organ transplantation
  • Active autoimmune disease or suspected autoimmune disease
  • Significant pleural effusion or ascites requiring treatment
  • Current or irreversible interstitial lung disease
  • Serious cardiovascular or cerebrovascular diseases
  • Active infection needing systemic treatment
  • Infectious diseases such as hepatitis B, hepatitis C, syphilis, or AIDS
  • Esophageal or gastric varices requiring intervention or high bleeding risk
  • Uncontrolled metabolic or systemic diseases that increase medical risks
  • Known allergy to study drug components
  • Pregnant or breastfeeding women
  • Other severe medical, mental, or laboratory conditions increasing study risks or affecting results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Actively Recruiting

2

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Actively Recruiting

3

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

4

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Actively Recruiting

5

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Not Yet Recruiting

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Research Team

Y

Yilong Wu, Prof. Dr. Med

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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